FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
MDR report key: 1931050
·
Received December 17, 2010
Report
- Report Number
- 3005075853-2010-07224
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- December 10, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT HAD A DIFFICULTY IN SEALING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |